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Completed

NCT Number: NCT01327352

Evaluation of the Influence of Food Regimen on Oshadi D Absorption

The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assaf Harofe Medical Center,

Zrifin, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Male/female 21 years old and up.
  • Subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
  • Subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.

Exclusion criteria

  • Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
  • Subject with positive HIV serology or positive HBsAg at screening.
  • History or evidence of any active liver disease.
  • Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
  • Inability to give written informed consent
  • History of alcohol or drug abuse within 6 months of screening.
  • Subject who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
  • Mental disorders.
  • Subject with poor venous access
  • Significant swallowing disorders
  • Digestive disorders;
  • Small bowel surgery;
  • Mall absorption disorders.

Treatment and study plan

Oshadi D

Drug

oral administration

Primary outcomes

  1. DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen

    Time frame: 24 hours

Secondary outcomes

  1. Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Oshadi Drug Administration

Industry

Registry information

Official study title

A Single Center, Non-randomized, Placebo Controlled Study for the Evaluation of the Influence of Food Regimen on Oshadi D Absorption

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2011
Registry last updated
Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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